Lack of concerns about reformulation of product among either Oncologic Drugs Advisory Committee members or FDA reviewers and the decades-long existence of the molecules raises questions as to why the meeting was needed.
The US FDA's Oncologic Drugs Advisory Committee unanimously backed Genentech Inc.'s subcutaneous formulation of rituximab by an 11-0 margin in a seemingly superfluous meeting.
Panelists raved about the clinical data of the new formulation of the monoclonal antibody – developed in combination with
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
